An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Cross Over Truncated Oral Bioequivalence Study Comparing Enzalutamide 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Xtandi® Enzalutamide 160 mg 80 mg ×2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 In Healthy Adult Human Male Subjects Under Fed Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To assess the bioequivalence of Enzalutamide 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India With XTANDI® Enzalutamide 160 mg 80 mgx2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 in Healthy adult human male subjects Under Fed Conditions
研究概览
简要总结
At least 32 number of healthy, adult, human male subjects will be recruited to evaluate the bioequivalence of Test product with the Reference product.
As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 32 subjects in period I alone.
Note:
If needed the study will be conducted as batch wise.
Demographic data, medical and medication history, physical examination, 12 lead ECG, hematology, biochemistry, serology, urine routine analysis will be done within 21 days and a chest X-ray within 06 months prior to check-in.
In each period, subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 30 days will be maintained between each dosing period.
Subjects will be served dinner on the day of check-in for each period. Thereafter, subjects will fast for at least 10.00 hours prior to high fat, high calorie non veg breakfast. High-fat, high-calorie non veg breakfast will be provided 30 minutes before dosing. Standard meals will be provided at 04.00, 08.00, 12.00, 24.00, 28.00, 32.00, 36.00, 48.00, 52.00, 56.00 and 60.00 hours post-dose respectively. All meal plans will be identical in all the periods of the study.
The subjects will fast for at least 10.00 hours prior to high-fat, high-calorie non veg breakfast and 04.00 hours post-dose
Blood pressure, radial pulse rate, body temperature, and wellbeing status will be enquired and recorded at pre-dose 00.00 hour (within 75 minutes of before dosing) and at 01.00, 02.00, 04.00, 06.00, 08.00, 12.00, 24.00 and 48.00 hours (± 60 minutes) post dose
Physical examination and vitals will be recorded before check-in, check-out (72.00 hours) for each period and at any time if necessary.
ECG will be recorded before check out (72.00 hours) for each period and if any subject is withdrawn or dropped out during the study.
Monitoring for adverse events will be done throughout the study period in clinical phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Normal healthy adult human male subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 29.99 kg per m2 Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physician or principal or clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Subjects willing to use adequate contraception during sexual intercourse with female partners of child bearing potential during the study and for a period of 03 months after receiving last dose of Enzalutamide.
排除标准
- •Evidence of allergy or known hypersensitivity to Enzalutamide or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins History of or risk factors for seizure Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaineCOC benzodiazepines BZD and morphine MOR in urine prior to check in of each period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of check-in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing.
结局指标
主要结局
To assess the bioequivalence of Enzalutamide 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India With XTANDI® Enzalutamide 160 mg 80 mgx2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 in Healthy adult human male subjects Under Fed Conditions
时间窗: 29 Time points | 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 06 50 hrs 07 00 hrs 07 50 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs
次要结局
- To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male subjects under fed conditions(29 Time points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited